Transvaginal bone anchor implantation device

ABSTRACT

The bone anchor implantation device of the present invention comprises a shaft or body having a grip at a first end of the shaft, an anchor mount at a distal end of the shaft, and a bone anchor removably mounted in the anchor mount. The shaft is preferably bent so that the anchor mount generally faces the grip such that the bone anchor can be implanted at an anchoring site in a bone by pulling rearwardly on the device. The body is adapted to be separable from the anchor after the anchor has been implanted in bone. A suture thread is attached to the bone anchor such that the suture thread is accessible to a surgeon using the device after the bone anchor has been implanted in bone and after the body has been separated from the bone anchor. The shaft is at least partially hollow, and the suture thread is housed in the shaft. The anchor mount comprises a cannula at the distal end of the shaft. The cannula is sized to removably receive an end of the anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of co-pendingapplication Ser. No. 09/111,525, filed Jul. 8, 1998, in the name of S.Robert Kovac, entitled A SYSTEM AND A METHOD FOR THE LONG TERM CURE OFRECURRENT URINARY FEMALE INCONTINENCE, and which is incorporated hereinby reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable.

BACKGROUND OF THE INVENTION

[0003] The invention relates to a system and method for the effectivelong-term cure of recurrent female urinary incontinence, and moreparticularly to a urethra stabilization and support system attached tothe posterior/inferior pubic bone and a method for accomplishing this inwhich a hypermobile urethra is repositioned in the anatomically properposition.

[0004] The problem of recurrent female urinary incontinence, or theinability to control urination, is a major and debilitating oneaffecting millions of women in the United States alone. One particulartype that frequently occurs in women is stress urinary incontinence,which is precipitated by coughing, straining, or heavy lifting. Mildcases may be treated by exercises involving tightening and relaxing ofthe perineal and gluteal muscles or by sympathomimetic drug therapy.Severe cases, however, may require surgery to correct the underlyinganatomic defect. It is this surgical correction which is the subject ofthe present invention.

[0005] In general, continence is considered to be a function of urethralsupport and coaptation. For coaptation to successfully prevent or cureincontinence, the urethra must be supported and stabilized in its normalanatomic position. The female's natural support system for the urethrais a hammock-like supportive layer composed of endopelvic fascia, theanterior vaginal wall, and the arcus tendineus (a distal attachment tothe pubic bone). Weakening and elongation of the pubourethral ligamentsand the arcus tendineus fascia pelvis, weakening of the endopelvicfascia and pubourethral prolapse of the anterior vaginal wall, and theircomplex interaction with intraabdominal forces are all suspected to playa role in the loss of pelvic support for the urethra and subsequenthypermobility to an unnaturally low non-anatomic position, leading tourinary incontinence.

[0006] Many procedures have been devised to treat urinary incontinencewith the goal of elevating the neck of the bladder to return it to ahigher retropubic position. Some involve the creation of a compensatorypubovaginal sling through a variety of needle suspension procedures;others employ a suburethral mesh to act as a compensatory suburethralsling to avoid the possibility that the sutures used in the needlessuspension procedures will easily tear.

[0007] Many of the needle suspension procedures involve placing suturesin the endopelvic fascia or the anterior vaginal wall on either side ofthe urethra and attaching them to fixation sites such as bone and softtissue. Alternatively, the sutures are attached to artificial anchorsplaced within the pelvis, at the superior border of the pubis, or rectusabdominus fascia. A major problem with this type of procedure is thatthe very fascial and muscular support structures that are sutured forsupport are often stretched, damaged, or otherwise deficient to beginwith, and remain so after the procedure. It is therefore difficult toemploy them successfully as reinforcements for surgical repair.

[0008] The pubovaginal sling procedure, in which a mesh is placed underthe urethra to provide elevation and support of the urethra and bladderneck, is performed through an abdominal incision, and has enjoyed anexcellent surgical success rate. It is generally preferable for morecomplicated cases of recurrent genuine stress urinary incontinence,particularly in patients who have failed prior surgery, who are obese,or whose lifestyles involve heavy lifting and accompanying increasedintraabdominal pressure. However, problems with voiding disjunction andurinary retention, detrusor instability, and infection and erosion ofsling materials that can lead to urethrovesical and vesicovaginalfistulas are cause for concern. Additionally, because of the abdominalincision, this procedure is more technically challenging, presentsgreater blood loss, longer operative time, and a prolonged postoperativerecovery.

[0009] These techniques use a variety of attachment sites for bladderneck and urethral support, such as the superior portion of the pubis,Cooper's ligament, or rectus abdominus fascia. This results in placementof the urethra in an unnaturally high position with respect to itsnormal anatomical retropubic position so that problems with voiding andurinary retention frequently arise after the procedure. Further, thisabnormal positioning of the urethra in conjunction with failure of thesupporting tissues and poor surgical technique have often led to arecurrence of incontinence since all of these operations create acompensatory abnormality rather than restoring the normal anatomy.

[0010] A related difficulty that contributes to the unnaturalpositioning of the urethra is that some attachment sites, such as therectus abdominus fascia, require very long sutures and accompanyingdifficulty in achieving the proper tension in the sutures. This canresult in increased lateral movement and momentum of the supportstructures or mesh sling when they are moved due to intraabdominalpressures.

[0011] The present invention addresses and corrects these and otherdifficulties by affecting the continence mechanism directly andproviding a predictable and lasting permanent cure for the problem ofrecurrent female urinary incontinence.

[0012] It has been found that the key site for control of continence hasnot been heretofore addressed. It has further been found that theurethral hypermobility observed in most incontinent patients is causedby a lax or torn arcus tendineus facie pelvis attachment at its originnear the anterior levator arch in the immediate retropubic position atthe site of the pubourethral ligaments. Repair and reinforcement of thisarea to stabilize the urethra in its normal position may be equallyimportant as repair of the endopelvic facie. Therefore, the key site forcontrol of continence is the paraurethral attachments of thepubourethral ligaments to the sides of the urethra at the intermediate60% of the urethral length. This is simulated through the employment ofa mesh sling system which supports this site and restores the bladderneck and urethra to their normal anatomic retropubic position.Additionally, when placed in this position, the lateral sides of themesh serve to act as pubourethral ligaments which help to prevent unduedescent of the urethra.

[0013] It has also been found that although the superior portion of thepubic bone is a functional and secure fixation site for incontinencerepair, a key to restoring the urethra to its normal anatomical positionis using the posterior/inferior border of the pubic bone, not thesuperior portion, as the attachment sites for the mesh sling system. Inparticular, the sling system is anchored to the pubic bone near thepoint of attachment of the arcus tendineus to the pubic bone. Propertensioning of the mesh sling system is made easier by using this portionof the pubic bone as the attachment site, due in part to the fact thatshorter sutures and an innovative mesh suturing pattern is used. Thisserves to avoid the problems heretofore discussed associated with animproperly high retropubic positioning of the urethra.

BRIEF SUMMARY OF THE INVENTION

[0014] According to the invention there is provided a pubic bone-mountedurethra stabilization and support system and a method for the long termcure of recurrent female urinary incontinence.

[0015] The system comprises a pair of anchors which are affixed to theposterior/inferior pubic bone near the point of attachment of the arcustendineus to the pubic bone, sutures attached to the anchors, and asling which is passed behind and about the urethra and the adjacentendopelvic fascia. Ends of the sling are attached to the anchors by theanchor-mounted sutures. In particular, a pair of anchor screws arelocated on either side of the symphysis pubis in the retropubic areaposteriorly and at about 0.5 cm superiorly of the inferior edge of theischial ramus. Sutures connect the anchor screws to the mesh sling. Themesh sling directly supports the urethra by its placement on theendopelvic fascia in the area of the intermediate 60 percent portion ofthe urethra as will be later described in greater detail.

[0016] The method includes the steps of accessing said urethra and pubicbone, properly locating and attaching the anchors to the pubic bone,properly locating the sling about the urethra and suturing andtensioning the ends of the sling to the anchors, causing said sling torestore, support and stabilize functional urethral continence anatomyand prevent urethral descent under intraabdominal pressure.

[0017] To access the urethra and pubic bone, a pair of divergentincisions are made, beginning at the posterior urethral fold, in theanterior vaginal wall. This creates a triangular flap to expose theoperative field. Care must be taken to separate the anterior vaginalwall from the adjoining endopelvic fascia to leave the endopelvic fasciaintact. Direct visualization and palpation is next employed to evaluatethe integrity of the lateral attachment of the endopelvic fascia to eacharcus tendineus fascia pelvis, repairing any damage by suturing ifnecessary.

[0018] The pubic bone is next located by palpation. The course of thearcus from the ischial spine to the arcus insertion into theposterior/inferior aspect of the pubic bone is palpated to locate theproper site for the anchor screws, which is at either side of thesymphysis pubis in the retropubic area posteriorly and at about 0.5 cmsuperiorly of the inferior edge of the ischial ramus. An anchor screw,which is provided with a pair of permanent sutures, is driven into thepubic bone at this location and set. An identical anchor screw is thendriven into a symmetrically located position on the other side of thesymphysis pubis.

[0019] A sling, which can be made of a substantially rectangular patchof surgical mesh, is next laid upon the endopelvic fascia such that itslongitudinal edges extend transversely of the urethra which is below theendopelvic fascia Four permanent sutures are used to transfix the meshalong the lateral borders of the urethra at the edges of the mesh. Thesesutures are so positioned as to create a slight trough-like spacebetween the mesh and the endopelvic fascia and urethra. This spaceprevents undue tension on the urethra by the mesh when the mesh isformed into a sling. The permanent sutures of the anchor screws are thenwoven transversely of the mesh in opposite directions between thelongitudinal edges of the mesh and inset from the transverse mesh edges.These sutures are then bilaterally tied with appropriate tensioning totransform the mesh into a sling.

[0020] Finally, any additional necessary repairs, including thesequential tying of the repair sutures for attaching the endopelvicfascia to the arcus tendineus fascia pelvis, are made. The cut edges ofthe anterior vaginal wall are approximated with sutures, and thecul-de-sac and posterior vaginal segment defects are repaired.

[0021] The bone anchor can either be a bone screw or a harpoon-typeanchor. If the bone anchor is a screw, it is preferably implanted usinga bone drill, such as disclosed in WO 97/30638. If a harpoon-type boneanchor is used, a transvaginal bone anchor implantation device of thepresent invention is preferably used. The bone anchor implantationdevice of the present invention comprises a shaft or body having a gripat a first end of the shaft, an anchor mount at a distal end of theshaft, and a bone anchor removably mounted in the anchor mount. Theshaft is preferably bent so that the anchor mount generally faces thegrip such that the bone anchor can be implanted at an anchoring site ina bone by pulling rearwardly on the device. The body is adapted to beseparable from the anchor after the anchor has been implanted in bone.

[0022] A suture thread is attached to the bone anchor such that thesuture thread is accessible to a surgeon using the device after the boneanchor has been implanted in bone and after the body has been separatedfrom the bone anchor. The shaft is at least partially hollow, and thesuture thread is housed in the shaft. The anchor mount comprises acannula at the distal end of the shaft. The cannula being sized toremovably receive an end of the anchor.

[0023] In use, the procedure is substantially the same as describedabove. The only difference lies in the method in which the bone anchoris inserted into the bone. Once the anchor site is located, the deviceis introduced into the patient transvaginally through the vaginal wallincision. The anchor is placed at the anchor site on the pubic bone, andthe device is pulled to drive the anchor into the pubic bone. Once theanchor has been implanted, the shaft is separated from the anchor andremoved from the patient. is hook shaped.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024]FIG. 1 is a fragmentary midsagittal cross-sectional view of thepelvic region illustrating the disposition of the urethra, bladder andvagina together with neighboring organs in a healthy woman;

[0025]FIG. 2 is a fragmentary transverse view generally as seen alongthe line 2-2 of FIG. 1, illustrating the pubic bone, the bladder, theurethra, the arcus tendineus fascia, the endopelvic fascia and thepubourethral ligaments;

[0026]FIG. 3 is a fragmentary midsagittal cross-sectional view, similarto FIG. 1, and illustrating the prolapse of the urethra against theanterior wall of the vagina;

[0027]FIG. 4 is a frontal surgical view of the external female genitaliain surgical preparation with the labia minora in open position exposingthe vestibule and the lower vagina of a female patient having theprolapse condition illustrated in FIG. 3;

[0028]FIG. 5 is a fragmentary surgical view, similar to FIG. 4, andillustrates the posterior orifice of the vagina distended by means of avaginal retractor, together with an incision made in the anterior wallof the vagina exposing the fascia tissue covering the urethra;

[0029]FIG. 6 is a fragmentary surgical view similar to FIG. 5 andillustrates the lateral edges of the incision stretched in open positionand the placement of a suture-bearing anchor screw retropubically at theposterior/inferior border of the pubic bone to the left of the pubicsymphysis and within 1 to 2 mm from the insertion of the arcus tendineusfascia pelvis;

[0030]FIG. 7 is a fragmentary surgical view, similar to FIG. 6, andillustrates both suture-bearing anchor screws in place in the pubic boneand a rectangular piece of surgical mesh overlying the urethra andsutured adjacent either side of the urethra to the endopelvic fascia;

[0031]FIG. 8 is a fragmentary surgical view, similar to FIG. 7, andillustrates the sutures of each anchor screw oppositely threaded throughits respective side of the mesh;

[0032]FIG. 9 is a fragmentary surgical view, similar to FIG. 8 andillustrates the anchor screw sutures being tensioned and tied, bringingthe lateral edges of the mesh into conjunction with the anchor screws,forming a sling support for the urethra;

[0033]FIG. 10 is a fragmentary midsagittal cross-sectional view, similarto FIG. 1, and illustrates the urethra, bladder and neighboring organsof a woman whose urinary prolapse has been corrected by the system ofthe present invention;

[0034]FIG. 11 is a fragmentary view of the pubic bone and the urethra,the urethra being supported by the system of the present invention;

[0035]FIG. 12 is an elevational view of another embodiment of a surgicalmesh sling;

[0036]FIG. 13 is an elevational view of yet another embodiment of asurgical mesh sling;

[0037]FIG. 14 is a plan view, partly in cross-section, of a transvaginalbone implantation device of the present invention; and

[0038]FIG. 15 is a fragmentary view of the bone implantation devicebeing used to implant a bone anchor in a pubic bone.

DETAILED DESCRIPTION OF THE INVENTION

[0039] Throughout the drawings, like parts have been given like indexnumerals. Reference is first made to FIGS. 1 and 2. These Figuresillustrate the location of the urethra and bladder of a healthy,continent female.

[0040] The pelvis is generally indicated at 1 in FIGS. 1 and 2. Theforward bony portions of the pelvis 1 a and 1 b (i.e. the pubic bone)are joined together by the pubic symphysis 2. The bladder 3 is locatedabove and behind the pubic bone 1 a and 1 b. The urethra extends fromthe bladder 3 downwardly to the urinary meatus 5.

[0041] The vagina 6 is located behind the bladder and urethra and issurmounted by the uterus 7 which overlies the bladder.

[0042] The upper 20 percent of the urethra constitutes theurethra-vesical junction 4 a or bladder neck portion. The lowermost 20percent 4 b of the urethra leads to the urinary meatus 5. Theintermediate 60 percent of the urethra (shown between index numerals 4 aand 4 b), is provided with a sphincteric mechanism, and support of thispart of the urethra is believed to be of key importance for continence.This is the part of the urethra which is subject to the greatestpressure as the result of prolapse.

[0043] Attention is again directed to FIG. 1, and particularly to FIG.2. It has long been understood that female continence is largely afactor of the proper support and stabilization of the bladder 3 andurethra 4 in their normal retropubic state and particularly duringcoughing, straining and the like. In the healthy, continent female, theurethra and bladder are separated from the extraabdominal area by ahammock-like supportive layer comprising the web of endopelvic fascia 8and the anterior vaginal wall 6 a As is most clearly shown in FIG. 2,the web of endopelvic fascia 8 is attached to the arcus tendineus fasciapelvis 9 at the right side of the pelvis (as viewed in FIG. 2) and tothe arcus tendineus fascia pelvis 10 on the left side of the pelvis (asviewed in FIG. 2). The arcus tendineus fascia pelvis 9 extends from theischial spine 11 to its insertion in the pubic bone portion 1 a at 12.Similarly, the arcus tendineus fascia pelvis 10 extends from the ischialspine 13 to the insertion of the arcus tendineus fascia pelvis in thepelvic bone portion 1 b, at 14.

[0044] The urethra 4 is additionally supported by a pair of pubourethralligaments 15 and 16. Pubourethral ligament 15 is attached to the side ofurethra 4 and extends forwardly to the pubic bone 1 a adjacent theinsertion 12 of the arcus tendineus fascia pelvis 9. In a similarfashion, the pubourethral ligament 16 extends from the opposite side ofthe urethra 4 to the pubic bone 1 b adjacent the insertion 14 of thearcus tendineus fascia pelvis 10. The attachment of the pubourethralligaments to the sides of urethra 4 are located at the above-notedintermediate 60 percent of the urethra.

[0045] From the above, it will be apparent that weakening of theendopelvic fascia 8, weakening of the anterior vaginal wall 6 a,weakening of the attachments to the pubic bone and stretching of thepubourethral ligaments 15 and 16 can result in urethral hyper-mobilityand incontinence. The sling of the present invention not only supportsthe urethra in its normal position, but also limits urethral descent atthe site of continence control. Since the urethra cannot be elevatedabove the level of attachment of the sling to the inferior/posteriorborder of the pubis, it functions only with increasing intraabdominalpressure to prevent urethral descent.

[0046] At this point, the manner in which the system of the presentinvention is applied and used will now be described. Reference is firstmade to FIG. 4 which is a frontal or surgical view of the femalegenitalia with the labia minora 17 and 18 parted to reveal the urethralmeatus 5 and the vestibule 19. The opening of the vagina 6 is shown at 6b. The anterior wall 6 a of the vagina is also shown. Prolapse of thebladder, the urethra and the anterior wall 6 of the vagina is evidencedby a bulging of the vagina (as shown) and the fact that the anteriorwall 6 a falls away less steeply than would be the case in a healthywoman. Depending upon the severity of the prolapse, the anterior wall 6a of the vagina may extend through the vaginal opening 6 b.

[0047] Reference is now made to FIG. 5. In this Figure the posteriorwall of the vagina and the adjacent portion of the vaginal opening 6 bare distended by means of a vaginal retractor 20. A pair of divergentincisions 21 and 22 is made, beginning at posterior urethral fold,indicated at 23. The portion 24 of the anterior vaginal wall 6 betweenthe incisions 21 and 22 is carefully separated from the endopelvicfascia 8 forming a triangular flap 24. The vaginal wall flap 24 can beused as a tractor to pull the operative field into better view. With theflap 24 in the position shown, it will be noted that a triangularincision, generally indicated at 25, results.

[0048] While incisions of other configurations can be used, the abovedescribed triangular incision 25 has certain advantages. First of all,the vaginal wall edges may be trimmed of excess material having beenstretched by prolapse. Furthermore, the endopelvic fascia has been leftintact with minimal damage to the local nerve supply to the urethra andbladder, and with little damage to the blood supply of the endopelvicfascia.

[0049] The endopelvic fascia attachment to the vaginal epithelium havingbeen separated, the incision 25 may be stretched to a more open positionand held in that position by retractors, or temporary stitches engagingthe adjacent drape, as shown at 26 in FIG. 6. At this point, dissectionis carried out laterally to assess the integrity of the lateralattachment of the endopelvic fascia to each arcus tendineus fasciapelvis 9 and 10. Evaluation is made by palpation and directvisualization. Repairs by suturing may be made, if required. Thesesutures are left untied until the system of the present invention is inplace. Additional repairs may also be made, if required.

[0050] The system of the present invention can now be put in place. Tothis end, a pair of pubic bone anchors (preferably screw anchors orharpoon type anchors) are located in the pubic bone portions 1 a and 1b. In FIG. 6, an anchor screw 27 is shown being drilled in place in thepubic bone portion 1 b. The site of the pubic bone anchor screw 27 isdetermined by palpating the course of the arcus 10 (see FIG. 2) from theischial spine 13 to the arcus insertion 14 into the posterior/inferioraspect of pubic bone portion 1 b. The anchor screw 27 is provided with apair of sutures 27 a and 27 b (FIG. 7) affixed thereto. The anchor screw27 and its sutures 27 a and 27 b are located within a driver 27 c which,in turn, may be mounted in a surgical drill (not shown). A non-limitingexample of such an anchor screw and driver is taught in U.S. Pat. No.4,632,100. With respect to the sutures 27 a and 27 b, excellent resultshave been achieved with permanent 0 sutures manufactured by Ethicon,Inc. of Summerville, N.J. and sold under the registered trademarkMersilene@.

[0051] Anchor screw 27 is placed approximately one fingerbreadthlaterally of the urethra 4 and approximately 1 cm laterally of thesymphysis pubis 2. The anchor screw 27 is then directed to theretropubic area approximately 0.5 cm posteriorly and superiorly from theinferior edge of the ischial ramus. This anchor site is near theinsertion point of the arcus tendineus to the pubic bone. Once theanchor site is located, the anchor screw 27 is driven into the pubicbone and is set. The sutures 27 a and 27 b are temporarily laid aside asis shown in FIG. 7. It will be understood that a second anchor screw 28will be attached to the pubic bone portion 1 a in precisely the samemanner and at the corresponding position on the pubic bone portion 1 a.This is shown in FIG. 7. The anchor screw 28 is provided with a pair ofsutures 28 a and 28 b which are laid aside as shown in FIG. 7.

[0052] A substantially rectangular patch 29 of surgical mesh,approximately 3 cm wide and 6 cm long is then provided. Excellentresults have been achieved by using a surgical mesh manufactured byEthicon, Inc. of Summerville, N.J. and sold under the registeredtrademark Mersilene®. The surgical mesh patch is shown in FIG. 7 at 29.The patch is provided with longitudinal edges 29 a and 29 b andtransverse edges 29 c and 29 d. The mesh 29 is laid upon the endopelvicfascia 8 with its longitudinal edges 29 a and 29 b extendingtransversely of the urethra 4 beneath the endopelvic fascia 8. Fourpermanent sutures are used to transfix the mesh 29 along the lateralborders of the urethra at the edges 29 a and 29 b of mesh 29. Thesesutures are shown at 30, 31, 32 and 33 in FIG. 7. The sutures are sopositioned as to allow a slight trough-like space between the mesh 29and the endopelvic fascia 8 and urethra 4. This trough-like spaceprevents undue tension on the urethra by the mesh when the mesh isformed into a sling, as will be apparent hereinafter. Excellent resultswere achieved when the sutures 30-33 constituted permanent 000 suturesmanufactured by Ethicon, Inc. of Summerville, N.J. and sold under theregistered trademark Ethibond®. It will further be noted in FIG. 7 thatthe mesh 29, from longitudinal edge 29 a to longitudinal edge 29 bextends along the above-described intermediate 60% of the length of theurethra 4, as indicated by the points 4 a and 4 b shown in FIG. 7.

[0053] Reference is now made to FIG. 8. In this Figure, it is shown thatthe permanent anchor sutures 27 a and 27 b of anchor screw 27 are woventransversely of the mesh 29 in opposite directions between thelongitudinal mesh edges 29 a and 29 b, and inset from the transversemesh edge 29 d. In a similar fashion, the anchor sutures 28 a and 28 bare woven transversely of mesh 29 in opposite directions between thelongitudinal edges 29 a and 29 b of the mesh, and inset from thetransverse mesh edge 29 c. The placement of the anchor sutures throughthe mesh is determined by placing upward tension on the mesh undercystoscopic guidance to determine the approximate tension required forurethral coaptation from each end of the mesh. As is shown in FIGS. 9and 10, the sutures 27 a and 27 b and sutures 28 a and 28 b are tied ina bilateral fashion to their respective points of attachment to thepubic bone portions 1 a and 1 b so that the transverse edges 29 c and 29d are gathered and are substantially adjacent the pubic bone. Thiscauses the mesh 29 to be transformed into a sling, the ends of which aresubstantially adjacent the pubic bone.

[0054] Thereafter, the repair sutures for attaching the endopelvicfascia to the arcus tendineus fascia pelvis 9 and/or 10 are tiedsequentially. Any mid-line or transverse defects are noted and repaired.Additional repairs may be made depending upon the requirement of theindividual patient. Then, the triangular flap 24 is removed and the cutedges of the anterior vaginal wall are approximated with absorbable 00polyglycolic sutures in a running fashion. At this point, the cul-de-sacand posterior vaginal segment defects are repaired. Cystoscopicexamination of the urethra and the urethral orifices with indigo carminedye are performed. Bladder drainage is provided by a suprapubiccystotomy.

[0055] Prior art incontinence procedures involving the use of a slinghave enjoyed excellent surgical success rates. They have, on the otherhand, been plagued with numerous drawbacks including voidingdysfunction, urinary retention, detrusor instability, infection, anderosion of the sling material. A number of these problems are, in alllikelihood, related to difficulty in achieving the proper tension of thesling.

[0056] The system of the present invention (i.e. the anchor screws 26and 28 and their placement, the sutures 26 a, 26 b, 28 a and 28 b andthe sling 29 and its placement) is characterized by a number ofadvantages (see FIG. 11). It is generally believed (as indicated above)that urethral hypermobility is caused by deficiencies in the arcustendineus fascia pelvis and the pubourethral ligaments. In addition, thepubourethral ligaments are subject to stretching or elongation. None ofthese damaged, or elongated, or deficient muscular and fascialparaurethral tissues is used to supply the support and stabilizationprovided by the system of the present invention. The system of thepresent invention does not hyperelevate the urethra (see FIG. 10) byattachment to the superior border of the pubis, to Cooper's ligament orto the rectus abdominus fascia. It is to be noted that in the normalcontinent female, the urethral position is never found to behyperelevated (see FIG. 1). By suturing the mesh sling of the presentinvention to anchor screws located, as described above, to either sideof the symphysis pubis in the retropubic area posteriorly and at about0.5 cm superiorly of the inferior edge of the ischial ramus, suchhyperelevation is precluded. The sutures that connect the mesh sling tothe anchor screws are, themselves, short which not only assists indeveloping the proper tension, but also minimizes lateral movement causeby intraabdominal pressure. Such movement is characteristic of longlength sutures. In addition, it will be noted that the sling of thepresent invention differs from the pubourethral ligaments primarily inthat the sling passes about and behind the urethra, rather than beingattached to the urethra sides. However, sutures 30 through 33 simulatean attachment to the urethra sides. Those portions of the sling betweeneach anchor and its respective pair of sutures 30-32 and 31-33 bear mostof the support load and closely simulate the pubourethral ligaments. Asa result of this, the sling not only serves much the same purpose as thepubourethral ligaments, but also serves much the same purpose as theendopelvic fascia and the anterior vaginal wall in a healthy woman. Thesling engages the urethra and stabilizes it by passing about theabove-described intermediate 60 percent of the urethra, believed to bethe primary continence control portion of the urethra. It has been foundthat repair of other site-specific defects of genital prolapse correctsonly those defects and does not alter the incontinence mechanism. Forexample, paravaginal repairs of the endopelvic fascia from one arcus tothe other can only be expected to correct the protrusion causing acystourethrocele. If the pubourethral ligaments are damaged, theirability to limit urethral descent with increasing intraabdominalpressures will remain impaired no matter how tight the endopelvic fasciais stretched from one arcus to the other.

[0057] Finally, the procedure of the present invention is a relativelysimple one and, as indicated above, proper tension on the sling is fareasier to determine than in prior art procedures.

[0058] The present invention has been described in the terms of vaginalinstallation of the system of the present invention. At this time, thisis the preferred procedure. Nevertheless, it will be understood that thesystem of the present invention could be installed abdominally orlaproscopically.

[0059] Reference is now made to FIG. 12 which illustrates anotherembodiment of the surgical mesh member which serves as a urethral sling.The mesh member is generally indicated at 34 and preferably is made ofthe same material described with respect to the surgical mesh member 29of FIG. 7. The surgical mesh member 34 is provided with a pair of holes35 and 36. The holes 35 and 36 are sized to just nicely receive theshanks of headed surgical anchor screws.

[0060] The procedure for installing the surgical mesh member 34 issubstantially identical to that described with respect to surgical meshmember 29, with the exception that surgical mesh member 34 is not tiedto anchors by sutures. Surgical mesh member 34 is provided with fourpermanent sutures equivalent to sutures 30-33 of FIG. 7 whereby it isattached to the endopelvic fascia 8. Again, the sutures are sopositioned as to allow a slight trough-like space between the mesh 34and the endopelvic fascia 8 and urethra 4. As indicated with respect tosutures 30-33 of FIG. 7, this trough-like space prevents undue tensionon the urethra by the mesh, when the mesh is formed into a sling.

[0061] An anchor screw (not shown) is caused to have its shank insertedthrough hole 35 in mesh member 34 and is located in theposterior/inferior aspect of the pubic bone portion 1 a. The site of theanchor screw is determined in exactly the same manner as that describedwith respect to anchor screw 27 of FIG. 7. In a similar fashion, theshank of a second headed anchor screw is passed through the hole 36 inmesh member 34 and is located in the posterior/inferior aspect of pubicbone portion 1 b.

[0062] Preferably, mesh member 34 is provided with more than one pair ofholes. In this way, the surgeon can select an appropriate pair of holesto achieve the best placement of the gauze member sling 34 when it isattached to the posterior/inferior aspect of the pubic bone portions 1 aand 1 b. To this end, mesh member 34 is shown 5 having a second pair ofholes 37 and 38.

[0063] Preferably, the holes 35-38 are provided with reinforcedstitching about their edges in a manner somewhat similar to buttonholes.

[0064] It is within the scope of the invention to shape the ends of themesh member. This is illustrated in FIG. 13 wherein the mesh member 39,having a first pair of holes 40-41 and a second pair of holes 42-43, isprovided with somewhat pointed ends 44 and 45. It will be understoodthat the ends may be otherwise shaped. For example, they could bearcuate or rounded.

[0065] The mesh sling elements 34 and 39 of FIGS. 12 and 13 tend tosimplify the surgical procedure since it is no longer necessary to weavepairs of sutures transversely of the mesh member ends as shown in FIG.8, and to tie these sutures as shown in FIG. 9. The number of pairs ofholes in the mesh elements 34 and 39 does not constitute a limitation ofthe present invention. Excellent results can be achieved using gauzeelements 34 or 39 having a length of about 6 centimeters and a width ofabout 3 centimeters.

[0066] The anchor used in the procedure described above is a bone screw,which is screwed into the pubic bone. Preferable, the screw is aself-tapping screw to avoid the need to pre-drill a hole which willaccept the screw. A harpoon-type anchor may be used in lieu of the bonescrew. Traditionally, harpoon-type anchors have been inserted into boneusing a straight shafted instrument. Such an instrument cannot be usedto implant a harpoon-type anchor in the posterior-inferior aspect of thepubic bone, especially when accessed transvaginally. To enable aharpoon-type anchor to be implanted in the pubic bone, the anchorimplantation device 100 shown in FIGS. 14 and 15 is used. The anchorimplantation device 100 of the present invention has a hooked shaft witha bone anchor mount for releasably engaging a bone anchor on the distalend of the shaft. This embodiment reduces the amount of force requiredto drive the bone anchor into the bone by utilizing the patient's bodyweight to provide an opposing force.

[0067] In this embodiment, the anchor implantation device 100 comprisesa handle 103, a hooked shaft 105 secured to the handle and a bone anchormount 107 at the distal end 111 of the shaft which releasably engages abone anchor 109. The bone anchor mount 107 generally points toward thehandle 103, such that the user can drive the bone anchor 109 into thebone by simply pulling back on the handle 103 and using the patient'sbody weight to provide an opposing force.

[0068] The shaft 105 comprises a straight proximal section 113, and agenerally curved section 115 at the end of the straight section 113giving the shaft a generally hooked shape. The anchor mount 107 is atthe end of the curved section 115 and comprises a hollow portion orcannula 116 at the distal end 111 of the shaft 105.

[0069] The shaft 105 is, at least partially hollow, to define a chamberor cannula which receives the sutures 117 secured to the end of theanchor 109. The cannula or chamber which receives the sutures can be acontinuation of the cannula 116 which receives the bone anchor 109.

[0070] The hooked bone anchor implantation device 100 is used asfollows. An incision is made in the anterior vaginal wall and the sitefor bone anchor implantation is located by palpation as described above.

[0071] The hooked bone anchor implantation device 100 is inserted intothe incision, and the bone anchor 109 is positioned against the pubicbone at the determined anchor site. The bone anchor 109 is then insertedor implanted into the bone by applying a retrograde force to the boneanchor 109. The retrograde force can be applied in a number of ways aswill be apparent to one of skill in the art. Preferably, the bone anchor109 is implanted in the bone by pulling the handle 105. For example, thehandle 105 may be pulled in a retrograde direction (toward the user) toimplant the bone anchor 109. As the device 100 is pulled in a retrogrademotion, the bone anchor 109 is driven into the pubic bone. The device100 is then pushed away from the implanted bone anchor 109 to disengagethe device 100 from the anchor 109. The device 100 is then removed fromthe incision, leaving the bone anchor 109 in the pubic bone with thesutures 117 extending therefrom. The urethra is then suspended andstabilized with the sling as described above.

[0072] As used herein and in the claims such works as “uppermost”,“lowermost”, “right”, “left”, and the like are used in conjunction withthe drawings for clarity.

[0073] Modifications may be made in the invention without departing fromthe spirit of it. For example, throughout the specification, the slingof the present invention has been described as a mesh sling. It will beunderstood by one skilled in the art that the sling could also be madeof other acceptable man-made materials, or of autologous fascia,cadaveric fascia, or other fascia. Although the device 100 as shown anddescribed is manually operated (i.e., it requires that the doctor pullback on the device to implant the bone anchor) the device 100 could bemodified to incorporate a pressurized gas supply, which, when released,would deliver a predetermined pressure to the anchor to implant theanchor in the bone without the need for the doctor to manually implantthe anchor. Furthermore, while the system and method of the presentinvention are described in their application to women, they could alsobe applied to men, as well. These examples are merely illustrative.

What is claimed is:
 1. A transvaginal bone anchor implantation device comprising a body including a first portion having a gripping end and a second portion having an anchor mount, and a bone anchor removably mounted in the anchor mount; the body second portion being angled relative to the body first portion when the device is in use such that the bone anchor can be implanted at an anchoring site in a bone by pulling rearwardly on the body first portion, the body being adapted to be separable from the anchor after the anchor has been implanted in bone.
 2. The transvaginal bone anchor implantation device of claim 1 wherein the body is bent, such that the body second portion mounting end generally faces toward the first portion gripping end.
 3. The transvaginal bone anchor implantation device of claim 1 wherein the body comprises a shaft.
 4. The transvaginal bone anchor implantation device of claim 3 including a suture thread attached to the bone anchor such that the suture thread is accessible to a surgeon using the device after the bone anchor has been implanted in bone and after the body has been separated from the bone anchor.
 5. The transvaginal bone anchor implantation device of claim 4 wherein the shaft is at least partially hollow, the suture thread being housed in the shaft.
 6. The transvaginal bone anchor implantation device of claim 1 wherein the bone anchor is a harpoon-type anchor.
 7. The transvaginal bone anchor implantation device of claim 1 wherein the anchor mount comprises a cannula at the distal end of the body second portion defines a hollow portion; the cannula being sized to removably receive an end of the anchor.
 8. A method of implanting a bone anchor in the pubic bone of a female patient comprising: creating an incision in the vaginal wall; locating an anchor site on the pubic bone; introducing an anchoring device into the patient transvaginally through the vaginal wall incision; the anchoring device comprising a body having a forward end and a gripping end and a bone anchor removably mounted to the forward end of the anchoring device; the forward end of the anchoring device facing generally toward the gripping end; placing the anchor at the anchor site on the pubic bone; pulling on the anchoring device to drive the anchor into the pubic bone; and separating the anchoring device body from the anchor and removing the anchoring device from the patient.
 9. The method of claim 8 wherein the anchoring device includes suture threads pre-attached to the anchor; the method including a step of making the suture threads available to the surgeon after the body has been separated from the anchor.
 10. The method of claim 9 wherein the anchoring device is at least partially hollow and the suture threads are housed in the anchoring device body; said step of making the suture threads available comprising the step of separating the anchoring device body from the anchor.
 11. The method of claim 10 wherein the step of locating the anchoring point on the pubic bone comprises locating the anchoring point on a posterior surface of the pubic bone.
 12. The method of claim 11 wherein the step of locating the anchoring point on the pubic bone comprises locating the anchoring point on an inferior, posterior surface of the pubic bone.
 13. The method of claim 12 wherein the step of locating the anchoring point on the pubic bone comprises locating the point of connection of the arcus tendineus to the pubic bone.
 14. A method of implanting a bone anchor in the pubic bone of a female patient comprising: locating an anchor site on the pubic bone; transvaginally introducing a bone anchor implanting device into the patient; the bone anchor implanting device comprising a body having a forward end and a gripping end and a bone anchor removably mounted to the forward end of the bone anchor implanting device; the forward end of the bone anchor implanting device facing generally toward the gripping end; placing the bone anchor at the anchor site on the pubic bone; pulling on the bone anchor implanting device to drive the bone anchor into the pubic bone; and separating the bone anchor implanting device body from the bone anchor.
 15. A bone anchor implantation device, comprising: an elongated member having a first end and a second end; and a bone anchor releasably engaged to said elongated member in the vicinity of said first end.
 16. A device for inserting a bone anchor into a bone comprising: a handle having a proximal end and a distal end; a shaft having a first end and a second end, said first end being connected to said distal end of said handle; and a bone anchor mount for releasably engaging said bone anchor, said bone anchor mount connected to said second end of said shaft and oriented toward said handle so that said bone anchor may be inserted into the bone by applying a retrograde force to said bone anchor.
 17. The device of claim 16 wherein said shaft is hook shaped.
 18. A method for inserting a bone anchor releasably engaged to a bone anchor implantation device into a bone comprising the steps of: locating a bone anchor implantation site on the bone; and applying a retrograde force to said bone anchor to implant said bone anchor into said bone.
 19. A method for inserting a bone anchor releasably engaged to a bone anchor implantation device into a bone comprising the steps of: locating a bone anchor implantation site on the bone; and pulling said bone anchor implantation device to implant said bone anchor into said bone.
 20. The method of claim 19 wherein said pulling step comprises applying a retrograde force to said bone anchor implantation device.
 21. The method of claim 20 wherein the locating and implanting steps are accomplished transvaginally
 22. The method of claim 19 wherein the bone anchor is implanted transvaginally into the pubic bone
 23. The method of claim 22 wherein the bone anchor is implanted in posterior pubic bone.
 24. The method of claim 23 wherein the bone anchor is implanted lateral to the symphysis pubis and cephalad to the inferior edge of the pubic bone.
 25. The method of claim 24 wherein at least one bone anchor is implanted on either side of the urethra.
 26. The method of claim 19 further comprising stabilizing the bladder neck with a suture attached to the bone anchor.
 27. The method of claim 19 further comprising: creating an opening in the tissue between the vaginal wall and the urethra; positioning a sling in the opening; and stabilizing the bladder neck with the sling using sutures connected between the sling and the bone anchors.
 28. The method of claim 27 wherein the two bone anchors are implanted on each side of the urethra.
 29. The method of claim 28 wherein one bone anchor on each side of the urethra is located lateral to the symphysis pubis and cephalad to the inferior edge of the pubic bone.
 30. The method of claim 29 wherein the second bone anchor is located on the cephalad aspect of the ramus. 